Deferred differentiation in migraine

How the anti-CGRP reimbursement landscape could shape in the near and long term

The best hope for CGRP antagonists to differentiate themselves lies in data that aren’t yet available. In the meantime, the makers of the migraine therapies will likely have to trade discounts on their already reasonable prices for favorable formulary status.

After decades of little progress in treating migraines, and only a handful of repurposed drugs to prevent it, on May 17, Amgen Inc.’s Aimovig erenumab-aooe became the first drug ever approved that was expressly developed to prevent the condition.

Its lone status was short lived, with two other drugs acting via the same mechanism approved in September, and a fourth likely by early 2020, setting up a showdown between four highly similar agents that will likely boil down to which company negotiates best with the payers.

Aimovig targets the calcitonin gene-related peptide (CGRP) receptor. Its competitors target the ligand. All four are mAbs.

Teva Pharmaceutical Industries Ltd.’s Ajovy fremanezumab-vfrm was approved by FDA on Sept. 14; Eli Lilly and Co.’s Emgality galcanezumab-gnlm was approved on Sept. 27. All three products are indicated for the preventive treatment of migraine in adults.

Alder Biopharmaceuticals Inc. plans to submit a BLA for eptinezumab early next year.

At this stage, there’s little difference among them. The four therapies have shown similar efficacy and safety in the clinic. The three marketed ones have the same wholesale acquisition cost (WAC) of $6,900 per year, which the Institute for Clinical and Economic Review (ICER) determined is cost effective, assuming a net price of $5,000 to payers after discounts (see “Getting Ahead of Headache”).

“Basically we know they work, they work quickly, and they have minimal side effects.”

Stephen Silberstein, Thomas Jefferson University

To make the strongest case possible to payers, Lilly and Amgen are gearing up to collect postmarket performance data. But those won’t be available in initial payer discussions.

Harvard Pilgrim Health Care Inc. CMO Michael Sherman told BioCentury payers are likely going to demand discounts, even though the products are

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